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SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00997061
Collaborator
(none)
500
Enrollment
61
Locations
27
Duration (Months)
8.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC.

Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan remains the responsibility of the patient's physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC.

Approximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
500 participants
Time Perspective:
Prospective
Official Title:
SCOT Registry: Small Cell Lung Cancer Treatment and Outcome
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
HYCAMTIN

Drug: HYCAMTIN
Observing patients on HYCAMTIN and other drugs for SCLC.

Outcome Measures

Primary Outcome Measures

  1. Registry with disease, treatment and outcome data collected. [6-9mth recruitment period, 18mth study duration.]

Secondary Outcome Measures

  1. survival rates [18 month period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or Female >/= 18 years

  • Diagnosis of small cell lung cancer

  • Patient newly diagnosed with SCLC

  • Has given written informed consent (if applicable)

Exclusion Criteria:

  • Concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.

  • Patient presenting with recurrence of SCLC.

  • Patients who has received any chemotherapy for the SCLC.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Graz Austria A-8036
2 GSK Investigational Site Innsbruck Austria A-6020
3 GSK Investigational Site Salzburg Austria 5020
4 GSK Investigational Site Vienna Austria 1130
5 GSK Investigational Site Brno Czech Republic 625 00
6 GSK Investigational Site Plzen Czech Republic 305 99
7 GSK Investigational Site Tallinn Estonia 11619
8 GSK Investigational Site Besançon France 25030
9 GSK Investigational Site Caen France 14033
10 GSK Investigational Site Créteil France 94010
11 GSK Investigational Site Draguignan cedex France 83300
12 GSK Investigational Site Lorient cedex France 56322
13 GSK Investigational Site Paris France 75020
14 GSK Investigational Site Perpignan France 66000
15 GSK Investigational Site Pessac cedex France 33604
16 GSK Investigational Site Pierre Benite France 69495
17 GSK Investigational Site Saint-Priest en Jarez France 42271
18 GSK Investigational Site Strasbourg France 67091
19 GSK Investigational Site Muenchen Bayern Germany 81925
20 GSK Investigational Site Immenhausen Hessen Germany 34376
21 GSK Investigational Site Kassel Hessen Germany 34125
22 GSK Investigational Site Wiesbaden Hessen Germany 65199
23 GSK Investigational Site Leer Niedersachsen Germany 26789
24 GSK Investigational Site Bonn Nordrhein-Westfalen Germany 53113
25 GSK Investigational Site Hemer Nordrhein-Westfalen Germany 58675
26 GSK Investigational Site Koeln Nordrhein-Westfalen Germany 51109
27 GSK Investigational Site Velbert Nordrhein-Westfalen Germany 42551
28 GSK Investigational Site Athens Greece 115 27
29 GSK Investigational Site Heraklion, Crete Greece 71110
30 GSK Investigational Site Thessaloniki Greece 57010
31 GSK Investigational Site Mátraháza Hungary 3233
32 GSK Investigational Site Székesfehérvár Hungary 8000
33 GSK Investigational Site Parma Emilia-Romagna Italy 43100
34 GSK Investigational Site Rozzano (MI) Lombardia Italy 20089
35 GSK Investigational Site Orbassano (TO) Piemonte Italy 10043
36 GSK Investigational Site Lecce Puglia Italy 73100
37 GSK Investigational Site Sassari Sardegna Italy 07100
38 GSK Investigational Site Seongnam-si, Gyeonggi-do Korea, Republic of 463-707
39 GSK Investigational Site Seoul Korea, Republic of 137-701
40 GSK Investigational Site Suwon, Gyeonggi-do Korea, Republic of 442-723
41 GSK Investigational Site Kaunas Lithuania LT-50009
42 GSK Investigational Site Klaipeda Lithuania LT-92228
43 GSK Investigational Site Vilnius Lithuania LT-08660
44 GSK Investigational Site Vilnius Lithuania LT-08661
45 GSK Investigational Site Amsterdam Netherlands 1081 HV
46 GSK Investigational Site Breda Netherlands 4818 CK
47 GSK Investigational Site Eindhoven Netherlands 5623 EJ
48 GSK Investigational Site Groningen Netherlands 9713 GZ
49 GSK Investigational Site Glucholazy Poland 41-340
50 GSK Investigational Site Gorzow Wielkopolski Poland 66-400
51 GSK Investigational Site Krakow Poland 31-115
52 GSK Investigational Site Lodz Poland 93-509
53 GSK Investigational Site Lublin Poland 20-954
54 GSK Investigational Site Warszawa Poland 00-909
55 GSK Investigational Site Golnik Slovenia 4204
56 GSK Investigational Site Ljubljana Slovenia 1000
57 GSK Investigational Site Cordoba Spain 14004
58 GSK Investigational Site Madrid Spain 28034
59 GSK Investigational Site Madrid Spain 28040
60 GSK Investigational Site Palma de Mallorca Spain 07014
61 GSK Investigational Site Zaragoza Spain 50009

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00997061
Other Study ID Numbers:
  • 112791
First Posted:
Oct 16, 2009
Last Update Posted:
Feb 3, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Topotecan

Study Results

No Results Posted as of Feb 3, 2014